Myocardial Infarction, Unstable Angina
Conditions
Keywords
Myocardial Infarction, Unstable Angina
Brief summary
Compare with regular regimen, the aim of this study is to testify whether having more statin during PCI will benefit in Chinese population, and to find out optimal dose of the drug for patient after PCI.
Detailed description
This study is designed to find out whether patients undergoing PCI can benefit from intensive atorvastatin treatment compared with routine treatment on chinese population.
Interventions
DRUGAtorvastatin
Atorvastatin 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care
DRUGStatin
Usual care, but statin dose should not be higher than that described in exclusion criteria
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 18-85 years old * Patients with clinical diagnosis of ACS * Evidence of a personally signed and dated informed consent document
Exclusion criteria
* Taking or, needing to take atorvastatin over than 20mg/d or any other equivalent statin in the next 6 months, or needing to take fibrates simultaneously according to investigators' judgment. * LDL-C \< 1.8mmol/L in patients without statin therapy in 1 months * Endstage congestive heart failure, or LVEF \< 30% * Active hepatic disease or hepatic dysfunction, or AST/ALT \> 1.5UNL * Myopathy or increased creatine kinase (CK\>2 UNL) * Severe renal dysfunction(Scr \> 3 mg/dl or 264μmol/L) * Allergic or experienced serious adverse reaction to HMG-CoA reductase, or ineligible to take statin as investigator's judgment * Severe aortic valve stenosis or severe mitral stenosis, Obstructive hypertrophic cardiomyopathy, pericardial diseases * Pregnancy, lactation, or child bearing potential women without any effective contraception * Accompanied with malignant disease or other disease, which cause life expectancy \< 6 months * Participating in other interventional clinical trails using drugs or devices * Patients with any condition which, in the investigator's judgment, might increase the risk to the subject for any adverse event or abnormal laboratory finding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30-day major adverse cardiovascular events (combined endpoints of cardiac death, myocardial infarction, and target vessel revascularization ) after PCI | 30-day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity of CIN | 48h | — |
| Elevation of ALT, AST and CK | 6 months | Proportion of patients who experience at least once AST\>3UNL，ALT\>3UNL or CK\>5UNL after initiation of study treatment. Proportion of patients who experience at least once AST, ALT, or CK\>UNL after initiation of study treatment. |
| Post-procedural change of inflammatory biomarkers (hs-CRP) | 24h | — |
| Combined endpoint of MACEs, cardiac hospitalization and cerebrovascular events | 6 months | Combined endpoint of death, cardiac death, myocardial infarction, heart failure, cardiac hospitalization, revascularization, and cerebrovascular events within 6 months after PCI. |
| serum adiponectin concentration | 6 months | — |
| Number of Participants with Adverse Events | 6 months | Proportion of patients who take reduced dose of atorvastatin, withdraw study treatment, or withdraw study due to adverse events |
Countries
China
Contacts
Primary ContactLing Tao, M.D Ph.D
Outcome results
None listed